Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy (REDENP)

Qingdao University

Status: Not yet enrolling

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Treatments: Diagnostic Test: High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07125586

MR-37-25-054863 (Other Identifier)

QYFYEC2025-73

Details and patient eligibility

About

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common condition causing nasal congestion, discharge, and reduced sense of smell, seriously affecting patients' quality of life. A subtype called eosinophilic CRSwNP (eCRSwNP) is difficult to treat and often recurs after surgery.

Currently, diagnosing this subtype requires tissue samples after surgery, which delays treatment decisions and may lead to unnecessary surgeries. Our research team has developed a new, non-invasive diagnostic system using advanced spectral technology to detect a natural fluorescence marker inside eosinophils (a type of immune cell) in nasal polyps. This system can quickly identify eCRSwNP before surgery by shining a safe light on the nasal tissue and analyzing the fluorescence signals.

This study aims to evaluate how accurate and safe this real-time diagnostic system is in clinical practice. If successful, it will help doctors choose better personalized treatments, reduce unnecessary surgeries, lower recurrence rates, and ultimately improve patients' lives.

Enrollment: 353 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female subjects aged 18 to 65 years old
2. Subjects diagnosed with CRSwNP by nasal endoscopy, CT, or MRI preoperatively (in accordance with the diagnostic criteria of EPOS 2020)
3. Normal coagulation function (prothrombin time [PT], activated partial thromboplastin time [APTT], and platelet count are within the normal range)
4. No severe cardiopulmonary dysfunction or other comorbidities that affect the tolerance of general anesthesia and surgery
5. Women of childbearing age must take appropriate medical contraceptive measures during the study period and within 4 weeks after the end of the trial treatment
6. Patients with good compliance, who voluntarily participate in this clinical study and sign the informed consent form.

Exclusion criteria

1. Patients with other nasal and paranasal sinus diseases excluding chronic rhinosinusitis (such as nasal tumors, fungal sinusitis, and post-traumatic nasal deformities)
2. Patients with coagulation dysfunction, immunodeficiency, or long-term use of anticoagulant/antiplatelet drugs at the time of visit, and females during menstruation
3. Patients who have taken oral glucocorticoids within 1 month prior to the visit
4. Patients with a history of nasal endoscopic surgery or nasal radiotherapy
5. Pregnant or lactating women, or those with severe systemic diseases (such as uncontrolled hypertension, diabetes, hepatic or renal insufficiency)
6. Patients with incomplete clinical data or missing postoperative follow-up data
7. Any other conditions deemed by the researcher as making the subject unsuitable for participating in the trial
8. Patients with poor treatment compliance

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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353 participants in 1 patient group

Evaluation of Eosinophilic CRSwNP Diagnosis Using High-Sensitivity Spectroscopy and Autofluorescence

Experimental group

Description:

Patients with CRSwNP (per EPOS2020 criteria) undergo non-invasive testing using a high-sensitivity spectroscopy system with autofluorescence to detect eosinophilic CRSwNP. A probe irradiates nasal polyps, capturing FAD autofluorescence signals (445nm excitation, \~525nm emission) for real-time classification. Tissue is obtained via biopsy or surgery for histopathological confirmation. Safety is assessed by monitoring mucosal irritation, swelling, or bleeding within 24 hours, with pain recorded via VAS (0-10). The study evaluates diagnostic accuracy (sensitivity ≥90%, specificity ≥85%) and safety (adverse event rate ≤3%).

Treatment:

Diagnostic Test: High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis